MeritMedical Cultura Flex Swab recall
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25…
Why was MeritMedical Cultura Flex Swab recalled?
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
- Product
- MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 3,385,442 units
- Distribution
- Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
- Recall date
- November 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)